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Comparative Study Between (MIPO)Submuscular Plate Fixation of Fracture Femur and Conservative Management With Thomas Splint in Children From 5 to 8 Years Old: A Randomized Clinical Study

NCT06543901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-09

No results posted yet for this study

Summary

This randomized clinical study compares the outcomes of two treatment methods for femur fractures in children aged 5 to 8 years: Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation and conservative management using a Thomas splint. The study evaluates the efficacy, safety, and recovery outcomes of both techniques. Key parameters include healing time, functional outcomes, complication rates, and patient and caregiver satisfaction. The findings aim to provide evidence-based recommendations for the optimal management of femur fractures in young children, balancing the benefits and risks of surgical versus non-surgical approaches.

Conditions

  • Femur Fracture

Interventions

PROCEDURE

Submuscular plating

the patient was fixed with a submuscular plate

PROCEDURE

Traction and casting

the patient was placed on a traction with a thomas splint and then was casted with a hip spica

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-01-01
Completion
2023-05-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06543901 on ClinicalTrials.gov